Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK

COVID Clinical Trial

— COVID19  

Official title:

Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405232
• Other study ID #: 20SM5934
• Status: Recruiting
• Start date: May 25, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: July 2020
• Source: Imperial College London
• Contact: Dr Deepa Jayakody Arachchillage, MRCP, FRCPath, MD
• Phone: 02073518401
• Email: d.arachchillage[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure [acute respiratory distress syndrome (ARDS)] and death is a global threat. On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic. As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths. Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1. Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets. The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries. Eventually >50% of people will have become infected and COVID-19 will remain a public health threat in the long term. It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death. Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients. In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment. Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future. Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 25, 2021
• Est. primary completion date: April 25, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/- radiological change +/- clinical suspicion in absence of RNA)

Exclusion Criteria:

• No exclusions

Related Conditions & MeSH terms

• Anticoagulation
• Bleeding
• COVID
• Thrombosis

Intervention

Other:
• Non-interventional
Observational study

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection		12 months
Secondary	Incidence of respiratory failure requiring CPAP or mechanical ventilation		12 months
Secondary	Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome		12 months
Secondary	Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality		12 months
Secondary	Incidence of clinically relevant non-major bleeding		12 months
Secondary	Incidence of Heparin induced thrombocytopenia		12 months
Secondary	Incidence of Acute coronary syndrome		12 months
Secondary	Incidence of renal failure requiring renal replacement therapy		12 months
Secondary	Incidence of Multiorgan failure		12 months
Secondary	Incidence of Development of DIC		12 months
Secondary	Duration of hospital stay (days)		12 months
Secondary	Hospital mortality		12 months